Analysis and Evaluation of EHR Approaches

Transcription

1 ehealth Beyond the Horizon Get IT There S.K. Andersen et al. (Eds.) IOS ress, Organizing Committee of MIE 008. All rights reserved. 359 Analysis and Evaluation of EHR Approaches Bernd G.M.E. BLOBEL 1 and eter HAROW ehealth Competence Center, Regensburg University Hospital, Regensburg, Germany Abstract. EHR systems are core applications in any ehealth/phealth environment and represent basic services for health telematics platforms. Many projects are performed at the level of Standards Developing Organizations or national programs, respectively, for defining EHR architectures as well as related design, implementation, and deployment processes. Claiming to meet the challenge for semantic interoperability and offering the right pathway, the resulting documents and specifications are sometimes controversial and even inconsistent. Based on a long tradition in the EHR domain, on the collective experience of academic groups such as the EFMI EHR Working Group, and on an active involvement at CE, ISO, HL7 and several national projects around the globe, an analysis and evaluation study has been performed using the Generic Component Model reference architecture. Strengths and weaknesses of the different approaches as well as migration pathways for re-using and harmonizing the available materials are offered. Keywords. EHR, Architecture, Models, Semantic Interoperability, Standards, ational rojects. Introduction The requirements for safe and high quality care as well as efficiency and productivity of health systems under the well-known constraining conditions are expected to be realized by increasingly distributed and specialized health services that become strongly oriented on the actual personal health status and the needs of the subject of care. Those health services are provided independent of time, localization, and distribution of resources in a highly communicative and collaborative way called ehealth. ehealth or personal health must be supported by basic technology paradigms of mobile computing for ubiquitous communications, of pervasive computing for comprehensive, and of pervasive care as well as autonomic computing for adaptive personalized system design enabling ubiquitous care altogether. Intentional communication and cooperation needs shared information for deriving collaborative actions which have to be observed for Quality Assurance (QA) purposes starting the information cycle again and again. rinciples and consequences considering the entire information cycle for meeting the semantic interoperability challenge are extendedly discussed in [1]. According to the 1 Corresponding Author: Bernd Blobel, hd, Associate rofessor; ehealth Competence Center, Regensburg University Hospital; Franz-Josef-Strauss-Allee 11, D Regensburg, Germany; hone: Fax: bernd.blobel@klinik.uni-regensburg.de;

2 360 B.G.M.E. Blobel and. harow / Analysis and Evaluation of EHR Approaches objectives and requirements of the actors involved in communication and cooperation, different levels for interoperability shall be provided thereby extending the interoperability chain up to the subject of care as demonstrated in the personal care paradigm s context []. Depending on the business case requiring interactions between systems, the following interoperability levels can be distinguished: technical interoperability (e.g. technical lug&lay, signal & protocol compatibility); structural interoperability (e.g. simple EDI, envelops); syntactic interoperability (e.g. messages, clinical documents, agreed vocabulary); semantic interoperability (e.g. advanced messaging, common information model and terminology); organizational/service interoperability (e.g. the common business process). The information about status and processes directly or indirectly related to the subject of care has to be documented in a computer-readable format, and stored in repositories - the Electronic Health Record (EHR). Such EHRs have to be implemented in EHR systems which are sets of components for realizing the mechanisms for creating, using, storing, and retrieving an EHR. EHRs and EHR systems for ehealth have to be based on an EHR architecture defining a model of generic properties required for every EHR to be communicable, comprehensive, useful, effective, and ethically-legally binding bewaring its integrity independent of platforms and systems as well as national specialties over the time [3], [4]. 1. Characteristics of Semantically Interoperable EHR Architectures For providing advanced and sustainable communication and cooperation, architectures for sustainable Health Information Systems (HIS) such as EHR systems have to be open, scalable, flexible, portable, distributed, standard-conform, semantically interoperable, service-oriented, user-accepted, applicable to any media, and lawful. Therefore, the following architectural paradigms have to be met: distribution; componentorientation; a model-driven and service-oriented design considering concepts, context, and knowledge; comprehensive business modeling; separation of platform-independent and platform-specific modeling (thus separating logical from technological view); agreed reference terminologies and ontologies; unified development process, and advanced security and privacy services embedded in the architecture. The aforementioned architectural paradigms are reflected in the Generic Component Model (GCM) which provides a multi-model approach to any system architecture [5]. Developed at the Magdeburg Medical Informatics Department in the early nineties, it can be used as reference architecture for analyzing, designing, and implementing EHR architectures characterized by their components, functionalities, and relationships but also for developing migration strategies [5], [6]. The respective reference architecture design is characterized by three dimensions (see Figure 1): the composition and decomposition of its components reflecting the complex functionality; from an enterprise viewpoint (explained in the next statement), it s the business process (workflow); the unified development process referring to the viewpoint of the ISO Information Technology Open Distributed rocessing Reference Model [7] starting with the extended business modeling of the enterprise view, the information view as its informational reflection, and the computational view as the reasonable functional aggregation of the components all three reflecting the platform-independent modeling and continuing with the platform-specific

3 B.G.M.E. Blobel and. harow / Analysis and Evaluation of EHR Approaches 361 models of the engineering view and the technology view, all five views summarized as development process (e.g. the Rational Unified rocess RU); the isolation and integration of the domain touched by the EHR (medical, administrative/organizational, legal, etc.). EHR systems as well as standards and projects defining them have to be assessed in reference to the GCM reference architecture. So, the usability of the analyzed approach, the gaps, and the capability for migration can be evaluated; the respective migration paths can be derived. Business Concepts Relations etwork Basic Services/Functions Basic Concepts Component Decomposition Component View Enterprise View Information View Computational View Engineering View Technology View Figure 1. The Generic Component Model Domain n Domain Domain 1. EHR-Related Standards Currently, three different streams for specification and implementation of advanced EHR architectures exist that have their roots in legacy systems, traditional imaginations, and methodologies: data approach (data representation), concept approach (concept and knowledge representation), and process/services approach (business process and service representation). Because of their rational roots, all approaches have their -at least temporary- right to exist. All approaches undergo further development offering a convergence. As the GCM considers all aforementioned aspects, the distance of evaluated approaches to the GCM as well as the reflection of the presented principles allow for the evaluation of developed or emerging solutions as well as for description of missing characteristics. Regarding EHR approaches as standards, specifications, or national projects, the following ones have to be investigated as the most important ones: the HL7 standards suite [8] with the HL7 RIM, HL7 v3, HL7 HDF, CDA, etc. most of them established, or under establishment, in ISO TC 15; ISO/E Health informatics EHR communications [9]; the GEHR [10] and openehr Foundations [11] projects; IHE approaches [1] but also service-oriented approaches such as CORBA components [13]; Web services, etc. The analysis only focuses on the architectural approaches ignoring national or project-specific specialties on implementation details, legal aspects, or priorities followed in some countries and their related projects. 3. Results Using the Generic Component Model, the different standards and projects influencing the global EHR development have systematically been evaluated. The results are summarized in Table 1. While in the study [14] all characteristics have been analyzed in detail, the table only reflects coarse grained quality parameters not considering either how the different aspects elaborated have been harmonized within the standards (quality and consistency). Due to the complexity of the ISO organization, standards might

4 36 B.G.M.E. Blobel and. harow / Analysis and Evaluation of EHR Approaches be referenced responding to some of the GCM requirements not inter-relating with EHR specifications, however, while the HL7 standard set provides such interrelationships as well as formal collaboration and joint projects solving those interrelations between SDOs. In that context, the unified process, separations of viewpoints, and the completeness of referencing ISO [7] have to be mentioned which are met in HL7 but not in CE/ISO or openehr, even if standards such as ISO E 1967 [15] are sometimes miss-referenced there. Table 1. Comparison of available EHR approaches (availability: -partial, -yes, -no, F-future) GCM Characteristics Development rocess Unified process Business modeling Service orientation View separation Completion of ISO System Architecture Reference information model Meta model Model transformation framework Concept representation Consistency of components Open concept representation language Composition/decomposition Signature/Certificate-enabled Machine-processeable Multi-Domain Suitability Domain-independent Domain separation Model multiplicity Ontology driven Vocabulary Reference to terminology Communication security services Application security services Inclusion of medical devices Specialty-related Multimedia-enabled Feasibility Visualization support Final specification available Implemented Commercial products available HL7 Standards n CCR 1 E/ISO F openehr IHE XDS F DICOM SR 4. Discussion and Conclusions The core application EHR is in the center of considerations for all European (e.g. EC ehealth Action lan) and national (UK, Denmark, USA, Finland, Australia, Canada) ehealth rogrammes. With the move by a paradigm change from organization-centered to process-controlled care and even further towards personalized healthcare, comprehensive communication and cooperation between all participants in the process including semantic interoperability between supporting information systems is inevitable. Different advanced approaches for future-proof architectures, EHR specifications, and the implementation of semantically interoperable EHR systems (e.g. HL7 Version 3 Standard Set with CDA, CCD, EHR-S Functional Model, EHR Interoperability Model [8], GEHR [10] /openehr [11], E/ISO [9], and CCR [16]) have been demonstrated, discussed, and evaluated using the GCM as reference architecture for sustainable and semantically interoperable health information systems [5]. The HL7 Version 3 methodology in connection with the definition of system requirements by the EHR-S Functional Model and the EHR-S Interoperability Model (it

5 B.G.M.E. Blobel and. harow / Analysis and Evaluation of EHR Approaches 363 remains a question to the author why both models have not been brought together) provides the best approach so far to GCM without solving domain-crossing aspects and the connection of non-ict views to ICT views. Furthermore, the formal business process specification and the dynamic behavioral/functional aspects of the components are still missing. The service-orientation missing could be overcome by current efforts of the SOA SIG in liaison [9]. Additionally, present concept representations have not been adequately integrated, probably due to a missing HL7 ontology. Surmounting the many solution islands, the complex HL7 Standards family could -in collaboration with CE, openehr and CORBA- demonstrate some progress. The second rather comprehensive approach to semantic interoperability is E/ISO [9], even if many deficiencies and inconsistencies have yet to be overcome. Contrary to the HL7 Version 3 approach, the problem of semantic composition / decomposition is insufficiently solved there. The same counts for business processes. On the other hand, the project orientates right from its beginning to the architecture paradigm despite of the irritating title, and it goes beyond the HL7 approach in this perspective. GEHR/openEHR [10], [11] has to be evaluated partly analogue to E/ISO due to the close connections and the common knowledge representation based on Archetypes. It constraints itself in essence to parts and 3, however. These two promising approaches suffer from the complexity of the healthcare domain. So, it will take some time before a critical mass of model-based services (metamodels at different levels or Archetypes, respectively, as well as tools for instantiation) will be available for revolutionizing health. Since 001, different pathways have been followed. While E/ISO still focuses on its architectural approach, the openehr Foundation project focuses on concepts bound to the clinical process leading to different structural components. At the same time, commonalities with HL7 CDA and HL7 Clinical Templates are increasing [8]. Contrary to HL7 Version 3 Standard Set and E/ISO 13606, CCR [16] provides an immediately applicable record solution without claiming semantic interoperability, however. All ways offered allow for migration using the GCM. A closer cooperation between standards bodies is absolutely helpful and thus required. During the evolution, the user community has to decide which interim solutions are acceptable. The necessity of meeting all paradigms of the GCM has been emphasized through experience from national projects in different countries the author has been involved in. Having been the internationally leading programme for introducing a national EHR for quite a long time, the Danish approach started with the underlying business processes in an exemplary way. The problem of structural and functional composition / decomposition has been ignored, however. This deficiency stopped the project now resulting in a comprehensive restart. Other projects and standards including the ones discussed here ignore the business processes, at the same time providing reasonable solutions for the other aspects. This has adverse effects as well in case the gaps have not been single-mindedly closed [17]. An important requirement for achieving semantic interoperability has been the establishment of a unified process including the definition of conformance statements as well as the quality assurance for specifications and implementations. Here, projects such as the European Q-REC led by the EuroRec Institute, and the work of the US Certification Commission for Health Information Technology (CCHIT) do push testing, quality labeling, or certification, respectively, of EHR specifications and EHR systems [18], [19].

6 364 B.G.M.E. Blobel and. harow / Analysis and Evaluation of EHR Approaches Currently, not any single specification investigated meets from an insider s perspective the requirements for semantic interoperability at service level but this is what almost all of them claim to do. The maturity of the approaches is very different whereby history of specifications and originating organizations, the chosen paradigm as well as scope and objectives are of importance. Maturing and harmonizing the present approaches in accordance with the GCM will provide the sustainable solution. Thereby, all architectural paradigms have to be met. Such component-based and service-oriented approach will lead to a layer of infrastructural services supporting creation, deployment, and maintenance of EHR systems. Most of the national strategies promote such development. The ehealth Competence Center (ehcc) located at the University of Regensburg Medical Center is involved in most of the international standardization activities and national programs related to EHR. While the work in many regions of the globe is ongoing and -more or less- evolved, the German EHR development starting with the bit4health (better IT for better health care) project that was launched some years ago by the German Federal Ministry for Health is comparably immature. Recently, the ehcc was appointed to specify the German EHR architecture. Acknowledgement The authors are indebted to their colleagues from standards bodies and institutions such as ISO, CE, HL7, the EuroRec Institute as well as related projects like GEHR/ openehr and Q-REC for kind cooperation and support. References [1] Blobel B: Introduction into Advanced ehealth The ersonal Health Challenge. In: Blobel B, harow, erlich M (Edrs.): ehealth: Combining Health Telematics, Telemedicine, Biomedical Engineering and Bioinformatics to the Edge The Global Experts Summit Textbook. Series Studies in Health Technology and Informatics, Vol IOS ress Amsterdam, Berlin, Oxford, Tokyo, Washington, DC, 008. [] Blobel B, harow, orgall T. How to Enhance Integrated Care towards the ersonal Health aradigm? In: Kuhn KA, Warren JR, Leong T-Z (Edrs.): MEDIFO 007, pp IOS ress Amsterdam, Berlin, Oxford, Tokyo, Washington, DC, 007. [3] ISO DTR 0514 Health informatics - Electronic Health Record Definition, Scope and Context [4] ISO TS Health informatics - Requirements for an Electronic Health Record Architecture [5] Blobel B. Advanced EHR Architectures romises or Reality. Meth. Inf Med 006; 45: pp [6] Blobel B: Educational Challenge of Health Information Systems Interoperability. Methods Inf Med 007; 46: pp [7] ISO Information Technology Open Distributed rocessing : [8] Health Level Seven Inc.: [9] E/ISO Health Informatics EHR Communications : [10] Australian Ministry for Health and Aging: The GEHR roject: [11] Beale T. A Model Universe for Health Information Standards (003): [1] Integrating the Healthcare Enterprise: see also [13] Object Management Group, Inc.: [14] DI roject. Internal Working Document on EHR Requirements. ehcc / DI Germany. [15] ISO CE 1967 Health Informatics - Service Architecture [16] American Society for Testing and Materials: [17] Bernstein K, Bruun-Rasmussen M, Vingtoft S, Andersen SK, øhr C. Modelling and Implementing Electronic Health Records in Denmark. International Journal of Medical Informatics, 004 [18] The Eurorec Institute: [19] Certification Commission for Healthcare Information Technology: